Clinical trials: Hepatic Insufficiency
Hepatic Insufficiency
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in…
- Trial name
- NCT02191865
- Testing
- Nintedanib
- Where
- Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Liver Cirrhosis
Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).
- Trial name
- NCT06478602
- Testing
- Fecal microbiota transplantation
- Where
- Romania
- Volunteers
- 19 people
- Sponsor
- Cristian Ichim
Hepatitis C, Medication Adherence
Intensive Models of HCV Care for Injection Drug Users
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival.
- Trial name
- NCT01857245
- Testing
- Intensive Models (mDOT and CGT) of HCV Care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Prisma Health-Upstate
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
Hepatic Encephalopathy
A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]
This is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the treatment of deep grade HE (West Haven…
- Trial name
- NCT02377947
- Where
- 3 sites in India
- Volunteers
- 50 people
- Sponsor
- Abbott
Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell
Project to Improve Communication About Serious Illness - Pilot Study
This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about…
- Conditions
- Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Lung Disease Chronic, Congestive Heart Failure
- Trial name
- PICSI-P (NCT03746392)
- Testing
- Jumpstart Intervention
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of Washington
Hepatitis C, Hepatitis C, Chronic
Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted liver.
- Conditions
- Hepatitis C, Hepatitis C, Chronic, Nonimmune Nonviral Causes of Liver Failure
- Trial name
- A-WISH (NCT00135694)
- Testing
- calcineurin inhibitor-based immunosuppression, liver transplant, corticosteroids
- Where
- 8 sites in United States
- Volunteers
- 275 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
End Stage Cardiac Failure, Pulmonary Failure
Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues such as skin, heart, lung…
- Conditions
- End Stage Cardiac Failure, Pulmonary Failure, End Stage Liver Disease, Morbid Obesity
- Trial name
- NCT00678834
- Testing
- To surgery patients, Tocopherol capsules., Tocotrienol to healthy subjects., To surgery patients, Tocotrienol capsules.
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Chandan K Sen
Acute Episode of Overt Hepatic Encephalopathy, Hepatic Encephalopathy
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
- Trial name
- STOP-HE (NCT01966419)
- Testing
- ornithine phenylacetate
- Where
- 131 sites in United States, Australia and 15 more
- Volunteers
- 231 people
- Sponsor
- Ocera Therapeutics, Inc.
Renal Impairment, Hepatic Impairment
Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment
The purpose of this study is to examine the effects of renal and hepatic impairment on TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with renal or hepatic impairment.
- Trial name
- NCT02367872
- Testing
- TAK-272
- Where
- 4 sites in Japan
- Volunteers
- 48 people
- Sponsor
- Takeda
Liver Failure
Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver Transplant
The purpose of this study is evaluate the medication vasopressin for its ability to preserve kidney function in patients undergoing liver transplantation.
- Trial name
- NCT00886262
- Testing
- Vasopressin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Acute Liver Failure
13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF
The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the…
- Trial name
- ALFSG-MBT (NCT02786836)
- Testing
- 13C-Methacetin
- Where
- 11 sites in United States
- Volunteers
- 76 people
- Sponsor
- University of Texas Southwestern Medical Center
Cirrhosis, Hepatic Encephalopathy
VE303 for Treatment of Hepatic Encephalopathy (HE)
This research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy.
- Trial name
- NCT04899115
- Testing
- VE303, oral vancomycin
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Patricia Bloom
Hepatic Insufficiency
A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment
The purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal…
- Trial name
- NCT01836185
- Testing
- Evacetrapib
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Severe Acute Alcoholic Hepatitis
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score >0.45).
- Trial name
- NCT01829347
- Testing
- ELAD, Standard of Care treatment
- Where
- 39 sites in United States, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- Vital Therapies, Inc.
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Hepatic Encephalopathy
Rifaximin in Minimal Hepatic Encephalopathy
The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic…
- Trial name
- NCT00533910
- Testing
- Rifaximin
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
End-stage Liver Disease (ESLD), Liver Transplant
A Physical Activity Program in End-state Liver Disease
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program.
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness
- Trial name
- NCT02776553
- Testing
- Nutritional consultation, Physical training program, Behavioral modification therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Arkansas
End Stage Liver Disease
A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
The goal of this pilot randomized trial is to assess the feasibility and preliminary efficacy of an advanced care planning (ACP) video decision support tool for improving patients' knowledge regarding their goals of care options…
- Trial name
- NCT03557086
- Testing
- Advance Care Planning Video Decision Support Tool, Verbal Narrative
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Massachusetts General Hospital